Fecal oxygenation

ABSTRACT

Provided are a device and method for oxygenating fecal matter in a patient. The device includes an interior material defining a plurality of oxygen packets including oxygen to be introduced into the patient&#39;s digestive tract. An outer coating applied to an exterior of the interior material protects the interior material from an environment of the patient&#39;s digestive tract when the device is consumed, and is dissolved by a substance within the patient&#39;s digestive tract to expose the interior material to the patient&#39;s digestive tract after a delay.

BACKGROUND OF THE INVENTION 1. Field of the Invention

This application relates generally to a method and composition fortreating an infection and, more specifically, a method and compositionfor in vivo exposure of bacteria to oxygen.

2. Description of Related Art

Clostridium difficile, referred to herein as “Cdiff,” is a significantpathogen with a very high mortality rate for immunocompromised patients.In the presence of oxygen, Cdiff becomes a self-protecting spore thatcan live for many months in a suspended state, awaiting reentry into amoist, no oxygen environment, like the lower intestines of a human. Oneconventional method for dealing with a Cdiff infection is transplantinganother person's processed feces into the colon of the infected person.The intention is to “dilute” the Cdiff with the more beneficial flora ofthe healthy person's feces. This procedure is commonly referred to as afecal transplant. Although fecal transplants can be effective, theprocedure is invasive and can be a lengthy process to effectively treatthe Cdiff infection.

BRIEF SUMMARY OF THE INVENTION

According to one aspect, the subject application involves a device andmethod for oxygenating fecal matter in a patient. The device includes aninterior material defining a plurality of oxygen packets includingoxygen to be introduced into the patient's digestive tract. An outercoating applied to an exterior of the interior material protects theinterior material from an environment of the patient's digestive tractwhen the device is consumed, and is dissolved by a substance within thepatient's digestive tract to expose the interior material to thepatient's digestive tract after a delay.

According to another aspect, the subject application involvesadministering a device for oxygenating fecal matter in a patient to thepatient orally, rectally, or via another route. Encapsulated oxygenpackets are protected from the environment within the patient'sdigestive tract, approximately until a time when the device enters aregion of the digestive tract where fecal matter is located. Whileexposed to the fecal matter within the digestive tract, an interiormaterial that was previously shielded is dissolved, releasing the oxygencontent within the oxygen packet into the fecal matter.

The above summary presents a simplified summary in order to provide abasic understanding of some aspects of the systems and/or methodsdiscussed herein. This summary is not an extensive overview of thesystems and/or methods discussed herein. It is not intended to identifykey/critical elements or to delineate the scope of such systems and/ormethods. Its sole purpose is to present some concepts in a simplifiedform as a prelude to the more detailed description that is presentedlater.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWING

The invention may take physical form in certain parts and arrangement ofparts, embodiments of which will be described in detail in thisspecification and illustrated in the accompanying drawings which form apart hereof and wherein:

FIG. 1 shows a schematic sectional view of a pill including a pluralityof oxygen packets to be released in a colon of a patient to oxygenatefecal matter;

DETAILED DESCRIPTION OF THE INVENTION

Certain terminology is used herein for convenience only and is not to betaken as a limitation on the present invention. Relative language usedherein is best understood with reference to the drawings, in which likenumerals are used to identify like or similar items. Further, in thedrawings, certain features may be shown in somewhat schematic form.

It is also to be noted that the phrase “at least one of”, if usedherein, followed by a plurality of members herein means one of themembers, or a combination of more than one of the members. For example,the phrase “at least one of a first widget and a second widget” means inthe present application: the first widget, the second widget, or thefirst widget and the second widget. Likewise, “at least one of a firstwidget, a second widget and a third widget” means in the presentapplication: the first widget, the second widget, the third widget, thefirst widget and the second widget, the first widget and the thirdwidget, the second widget and the third widget, or the first widget andthe second widget and the third widget.

There is a need in the art for a method and composition for treating aClostridium difficile (“Cdiff”) infection, and possibly otheroxygen-sensitive infections, with a time-delayed release of oxygen.Using Cdiff as an example of a treatable infection, Cdif does not thrivein the presence of air or other oxygen-rich environment. Accordingly,the present disclosure involves introducing air or other source ofoxygen to a region of a human body where the Cdiff infection resides, toreduce the volume of thriving Cdiff present. The oxygen can beintroduced to the affected region via an oral, rectal, or any othersuitable route. The oxygen can be introduced encapsulated in a shellthat can deteriorate in the presence of bodily fluids or othersubstances present in and around the region where the Cdiff bacteria arepresent and along the route of administration to the region where theCdiff bacteria are present.

According to a method, oxygen can be introduced to the infected Cdiffregion, such as in the large intestine and colon, optionally using acatheter type arrangement where oxygen is pumped into the largeintestine, color or other region located in the lower portion of thepatient. According to another embodiment, fecal transplant material thatis to be transplanted into a patient can optionally be oxygenated (e.g.,oxygen is introduced to the fecal material to elevate the amount ofoxygen present to levels above the oxygen level naturally present in thefecal transplant material prior to the introduction of the oxygen).Introducing oxygen into the material itself is believed to provide somebenefit, but the volume and longevity of the oxygen in thisconfiguration may be limited to an extent that renders the presentembodiment of limited usefulness.

According to alternate embodiments, the present disclosure is directedtowards a method and composition to provide a prolonged release ofoxygen into the Cdiff-affected zone (e.g., the large intestine, colonand other regions that would otherwise be affected by a fecaltransplant). One embodiment of the present method involves introducingand embedding encapsulated oxygen into the fecal transplant materialthat is to be transplanted into a patient. Encapsulated oxygen caninclude oxygen-rich substances such as air, purified oxygen, etc.encapsulated within a shell that dissolves, degrades, or otherwisechanges to release the encapsulated oxygen. Based at least in part onthe properties of the shell, the oxygen can be released from the shellover a predetermined period of time, and/or begin to release theencapsulated oxygen after a predetermine threshold period of time hasexpired from a time when the encapsulated oxygen is introduced to thefecal transplant material, the infected patient, or both. For example,the thicknesses of shell material encapsulating the “oxygen packets”,that, due to their thickness and corresponding varying times required todissolve, cause a time delay from when the shell is introduced to thefecal transplant material or patient before the oxygen is released fromthe shell. According to alternate embodiments, the specific chemicalcomposition of the shell material itself can be configured to establishthe desired time-delayed aspects of the encapsulated oxygen. Yet otherembodiments utilize a combination of the shell structure (e.g.,thickness) and the shell composition (e.g., chemical composition) tocontrol the delay between when encapsulated oxygen is introduced to thefecal material and/or patient and a time when the oxygen release begins,and/or to control the duration of the oxygen release.

With reference to the drawings, FIG. 1 shows an embodiment of a pill 100including encapsulated oxygen packets 105. An outer coating 110 of thepill 100 encapsulates an interior material 115 defining the oxygenpackets 105. The outer coating 110 can be formed from a first materialthat dissolves at a known rate within the digestive tract of the patientwhen consumed orally. The first material forming the outer coating 110can be approved by a government regulatory body (e.g., U.S. Food andDrug Administration) for human consumption. The outer coating 110 canalso be formed with a thickness T to enable the outer coating 110 toremain substantially intact as the pill 100 travels along the patient'sdigestive tract, through the patient's stomach. For example, the outercoating 110 can optionally encapsulate the interior material 115 (e.g.,shield the interior material 115 from exposure to bodily fluids of thepatient) for at least four (4) hours, or at least six (6) hours, or atleast eight (8) hours from a time when the device is ingested. At aboutthe time when the pill 100 reaches or approaches the top of thepatient's colon, the outer coating 110 can be at least partially, andoptionally mostly or fully dissolved, degraded, or otherwise compromisedto at least begin exposing a portion of the interior material 115 to theenvironment within the colon. For example, the outer coating 110 can beformed from materials such as a guargum or chewing gum type substancethat is able to withstand gastric acids and make its way until shortlybefore, or shortly after entering the colon along the digestive tract.

The interior material 115 defines therein a plurality of oxygen packets105 in which air (having an oxygen concentration of about 21% byvolume), purified oxygen (e.g., having an oxygen concentration ofgreater than 21% by volume, or greater than 40% by volume, or greaterthan 60% by volume, or greater than 80% by volume, or greater than 90%by volume). The interior material 115 can be formed from a secondmaterial, different than the first material, and dissolves at a knownrate within the digestive tract of the patient when consumed orally. Thesecond material forming the interior material 115 can be approved by agovernment regulatory body for human consumption. The oxygen packets 105can optionally be substantially uniform in dimensions and/or volume, orcan vary in dimensions and/or volume. For embodiments where thedimensions and/or volumes vary, the oxygen packets 105 can bedistributed according to a patter. For example, oxygen packets 105 withrelatively large volumes of oxygen can optionally be arranged adjacentto a center of the interior material 115, and oxygen packets 105 withrelatively small volumes of oxygen can optionally be arranged adjacentto an outer periphery of the interior material 115. For such anembodiment, a greater volume of oxygen is released from the oxygenpackets 105 as the interior material 115 dissolves, degrades or isotherwise consumed from the outside toward a central region in withinthe colon. Of course the oxygen packets 105 can be arranged in anydesired pattern without departing from the scope of the presentdisclosure.

As noted above, the outer coating 110 can be configured in thickness,chemical composition, etc., to last and protect the interior material115 and encapsulated oxygen packets 1005 through the digestive tractuntil the pill 100 makes its way to the vicinity of the top of thecolon. Similarly, the interior material 115 can be configured indimensions, chemical composition, density, etc. to continuouslydissolve, degrade or otherwise release the oxygen packets 105 for atleast a portion of the time the pill 100 travels through the colon. Theinterior material 115 separating the oxygen packets 105 can also bedefined with varying dimensions (e.g., thickness) to regulate the lengthof time over which the oxygen packets 105 are released. Thinner interiormaterial dimensions between oxygen packets 105 will cause the oxygenpackets 105 to be released in close succession, allowing the oxygen toescape sooner in the digestive tract, while thicker interior materialdimensions will space out the oxygen releases and take longer for alloxygen packets 105 to be released. In this way a continual dose can beprovided over time as the pill 100 makes its way through the bodysystem, releasing oxygen as it goes.

According to alternate embodiments, the interior material 115 can beconfigured in composition and dimensions to dissolve, degrade orotherwise release most of the oxygen packets 105 in response to enteringthe colon and being exposed to the patient's fecal matter. For example,the composition of the interior material 115 can include a time-releasesubstance that slows a rate at which the interior material 115 degradeswithin the digestive tract to a slower rate. The slower rate ofdegradation can be slower than the natural rate of degradation of theinterior material 115 without the time-release component. Such a pill100 can release the encapsulated oxygen packets 105 to oxygenate thepatient's fecal matter early in the colon, potentially increasing thetime the patient's fecal matter is exposed to pure, orsubstantially-pure oxygen. The release of oxygen can then continue foras long as the interior material 115 defines oxygen packets 105 thathave yet to be compromised.

Although described above as an orally ingestible pill 100, the pill 100can optionally be configured as a rectally inserted suppository that ismuch larger and contains more oxygen packets 105 than a pill 100 takenby mouth. Rectal insertion of such a pill 100 can be done in a hospitalsetting, or at another healthcare facility where medical treatment isadministered. Further, because such a pill 100 does not necessary haveto withstand exposure to stomach acids, etc. before reaching the colon,the outer coating 110 for the suppository can optionally be configured(e.g., chemical composition and/or dimensions) expose the interiormaterial 115 sooner upon introduction into the patient than a pill 100consumed orally.

Another embodiment involves surgical attachment of the suppositoryembodiment of the pill 100 to the inner wall of the colon with adissolvable suture that holds this pill 100 in place long enough forall, or at least a portion of the oxygen packets 105 to be releasedbefore being passed.

According to alternate embodiments, the pill 100 can also optionallyencapsulate a high organic load, fiber and/or other nutritional,medicinal and/or therapeutic component (referred to as an “additive”) tohelp promote a healthy population of bacteria within the colon. Theadditive chosen can optionally flourish under the increased oxygencontent of the patient's fecal matter, providing additional benefit tofighting the Cdiff infection by further diluting the Cdiffconcentration, and promoting desired bowel function.

Illustrative embodiments have been described, hereinabove. It will beapparent to those skilled in the art that the above devices and methodsmay incorporate changes and modifications without departing from thegeneral scope of this invention. It is intended to include all suchmodifications and alterations within the scope of the present invention.Furthermore, to the extent that the term “includes” is used in eitherthe detailed description or the claims, such term is intended to beinclusive in a manner similar to the term “comprising” as “comprising”is interpreted when employed as a transitional word in a claim.

What is claimed is:
 1. A device for introducing oxygen to a portion of apatient's digestive tract, the device comprising: an interior materialdefining a plurality of oxygen packets including oxygen to be introducedinto the patient's digestive tract; an outer coating applied to anexterior of the interior material, wherein the outer coating protectsthe interior material from an environment of the patient's digestivetract, and is dissolved by a substance within the patient's digestivetract to expose the interior material to the patient's digestive tractafter a delay.
 2. The device of claim 1, wherein the interior materialcomprises a time-release material that retards a rate of degradation ofthe interior material in the patient's digestive tract from a naturalrate at which the interior material degrades without the time-releasematerial.
 3. The device of claim 1, wherein the oxygen packets definedby the interior material store a plurality of different volumes.
 4. Thedevice of claim 1, wherein the oxygen concentration of the oxygen withinthe oxygen packets is at least 40% by volume.
 5. The device of claim 1,wherein the oxygen concentration of the oxygen within the oxygen packetsis at least 60% by volume.
 6. The device of claim 1, wherein the outercoating encapsulates the interior material for at least four (4) hoursfrom a time when the device is ingested.
 7. The device of claim 1further comprising an additive comprising at least one of: concentratedfiber, a nutrient, a medicinal substance, and a therapeutic component.